MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN; COCHLEAR BAHA CONNECT SYSTEM

Model Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient experienced infection at implant site.Subsequently the device was explanted (date not reported).

Manufacturer Narrative

Correction: the device was not explanted as initially reported.Only the abutment was removed.

• Brand Name: UNKNOWN
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7106313
• MDR Text Key: 94467885
• Report Number: 6000034-2017-02312
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention